Reported Aug 19, 2026 · Ongoing · Updated Aug 25, 2026
Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator ,…
Galt Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Galt Medical Corporation · 2220 Merritt Dr · Garland, TX · 75041-6137
Is this the product you have?
- Boston Scientific Enhance
- Transcarotid/Peripheral Access Kit REFSR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock
- Lot codes and dates
- UDI00841268107250/Lot:
237 of 237 codes
G22171212G22201213G22201214G22201215G22201216G22201217G22201218G22234219G22234220G22262227G22234221G22234222G22234223G22262225G22234224G22262226G22262228G22262229G22262230G22292231G22292232G22292233G22292234G22292235G22292236G22292237G22320238G22320239G22320240G22320241G22320242G22320243G22320244G22354191G22362192G22362194G22362195R23083454G23076104G23076105G23083106G23083107G23083108G23083109G23111110G23111111G23111112G23111113G23111114G23111115G23146116G23146117G23146118G23146119G23146121G23146120G23174122G23174123G23174124G23174125
- UDI00841268107250/Lot:
- Amount recalled
- 114,260 kits
Where it was sold
- Nationwide
- MN
Why it was recalled
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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